Multi-Centre, Retrospective, Open Label Study, to Validate ML-PrediCare by Patients With Melanoma Under 1st and 2nd Lines of Immunotherapy

NCT02581228 | Unknown

• 1 other identifier: OPTI-007
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This is a retrospective, open label study to establish and validate a prediction technology for advanced melanoma patients under the 1st, 2nd and later treatment lines, with the immunotherapeutic drugs Ipilimumab, Pembrolizumab \& Nivolumab, in order to predict response rate and disease progression

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• The primary endpoint in this study stage is Time to Progression of disease

  1 year

Study Arms (2)

Training Set

The objective of the Training stage is to assess the predictive potential of ML-PrediCare for melanoma patients' response to Ipilimumab, Pembrolizumab and Nivolumab.

Device: ML-PrediCare

Validation Set

The objective of the Validation stage is to test the predictive power of ML -PrediCare in an independent set of patients diagnosed with melanoma.

Device: ML-PrediCare

Interventions

ML-PrediCare DEVICE

Training Set; Validation Set

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Data from up to about 500 melanoma patients will be screened for collection, depending on data availability and completeness of the files

You may qualify if:

• Patients who meet all of the following criteria are eligible for this study:
• Gender: Female, Male.
• Age: Eighteen years and older at the start of treatment.
• Histologically confirmed unresectable Stage III or Stage IV melanoma, as per AJCC staging system.
• Prior radiotherapy must have been completed at least 2 weeks prior to drug administration.
• Measurable disease by CT, or PET-CT, or MRI per RECIST 1.1
• Patient has at least one quantitative measurement of at least one target lesion (primary tumor or metastasis) before treatment.
• Patient has at least one quantitative measurement of at least one target lesion (primary tumor or metastasis) during or after the treatment.
• Patient has at least one recorded visit to the treating oncologist before treatment.
• Patient has at least one recorded visit to the treating oncologist during or after the treatment.
• Treatment as per SOC for melanoma.

You may not qualify if:

• Patients meeting one or more of the following criteria are ineligible for this study:
• History of another malignancy within the previous 2 years except for:
• Adequately treated Stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 2 years
• Ocular melanoma
• Active brain metastases or leptomeningeal metastases.

Sponsors & Collaborators

• Optimata Ltd.: lead

Study Sites (1)

Optimata Ltd.

Bne ‘Atarot, 60991, Israel

RECRUITING

Related Publications (1)

• Tsur N, Kogan Y, Avizov-Khodak E, Vaeth D, Vogler N, Utikal J, Lotem M, Agur Z. Predicting response to pembrolizumab in metastatic melanoma by a new personalization algorithm. J Transl Med. 2019 Oct 7;17(1):338. doi: 10.1186/s12967-019-2081-2.

  PMID: 31590677 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tumor tissue from an unresectable or metastatic site of disease will be collected for biomarker analyses. Paraffin-embedded tissue samples from patients treated with the immunotherapy drugs (with the previously obtained inform consent form) will be collected from the tissue bank of the hospital and according to the European Commission regulations.

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Marina Kleiman, PhD

  Optimata Ltd.

  STUDY DIRECTOR

• Michal Lotem, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina Kleiman, PhD

CONTACT

972-7519226; marina@optimata.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: October 20, 2015
• Study Start: October 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: November 1, 2018
• Last Updated: September 27, 2016

Record last verified: 2016-09

Locations

IL (1)